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FDA reviewers report an area under the ROC curve of 0.81 against the majority judgment, above a goal of 0.75. Sepsis was present in 3.02% of the low risk group and 69.70% of the very high risk group. In-hospital death rose from 0% in the low group to 18.18% in the very high group. FDA granted the De Novo request on 2 April 2024. The study was retrospective, so the score did not guide care, and adjudicators worked at the same hospitals as the patients.","category":"general benefit","unexpected":false,"purpose":"The Sepsis ImmunoScore was built to identify patients at risk of having or developing sepsis within 24 hours. 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